MISSIONMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSITION SUMMARYThe SVP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure and functioning of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company. The SVP leads the department and also works collaboratively across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system. The SVP of Drug Safety & Pharmacovigilance will interface with vendors, external experts, business partners, investigators, and government agencies. JOB FUNCTIONS/RESPONSIBILITIESOversee the Mirum global PV system to enable compliance with global PV regulatory requirementsCreation of organizational strategy, goals and objectives for the department and ensure implementation of business plans to support both US and international global safety strategiesMaintain awareness of new and emerging safety concerns and related communications to the competent authorities in a time frame appropriate to the benefit-risk assessment of Mirum’s productsResponsible for all medical safety aspects of clinical development and post market surveillance of medicinal products in the Mirum portfolioStrategic oversight and overall responsibility of commercial safety reporting requirements for US, EU and other international territories, as required.Management, oversight and mentorship of staff able to set the strategy for future Drug Safety & PV department build and planningPartner with clinical development representatives to lead safety signal assessments and validate safety signalsCommunicate important safety information to appropriate stakeholders, including executive management, as appropriateParticipate in health authority interactions (both written and verbal) and inspections regarding safety risk management; oversees team members who support such interactionsOversight of Drug Safety Committees & Core Safety InformationContribute written summaries and provide safety review for safety components of protocols, IB, clinical study reports, regulatory submissions, label negotiations etc. by working directly with team members and offering strategic and tactical support when neededOversee, Write or Review of periodic aggregate/safety reportsPerform Benefit-Risk Assessments in collaboration with Clinical Development, as requiredEnsure compliance with global safety requirements and inspection readiness, including root-cause analysesManage relationships with clients and team members providing expert safety knowledgeSupport the evaluation of business opportunities, as directed by executive managementQUALIFICATIONSEducation /Experience:MD, PharmD or equivalent degreeMinimum of fifteen (15+) years Pharmacovigilance experience with at least five (5) years of department management experienceExperience in building teams, directly or matrixed and leading projectsExperience in risk management strategies and signal detection strategiesRobust knowledge of global PV requirementsExperience overseeing safety/PV vendorsExperience with regulatory authority inspectionsAbility to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs, as well as commercial productsStrong business acumen and ability to negotiate and collaborate with cross-functional partners to achieve department and company goalsEffective written, verbal communication and interpersonal, relationship-building skillsProven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projectsOrganized, attention to detail, and able to meet timelines in a fast-paced environmentAble to work with a high level of autonomy and independenceKnowledge and understanding of global regulatory requirements for product approval and compliance#LI-HYBRIDMirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
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